1. Technical Field
The subject invention relates to a composition for the disinfection of biological fluids and uses thereof. The invention also relates to methods of using the composition.
2. Background Information
A major concern among laboratory personnel is the handling of potentially infected blood and other samples for the purpose of laboratory testing. Patient samples can be potentially hazardous to the persons handling or performing the laboratory tests since the samples are capable of transmitting infectious or disease-causing agents.
Since all patient samples must be considered potentially dangerous, the cost of protective measures continues to rise while the efficacy of these measures remains to be determined. (American Hospital Association, "AIDS/HIV Infection: Recommendations for health care practices and public policy," AHA Report (1988)).
Furthermore, another concern involves protecting those individuals receiving blood transfusions, as these individuals are particularly at risk of contracting blood-transmitted diseases. Current trends in the practice of transfusion medicine are focused on enhancing the sterility of donor blood, especially from the standpoint of blood-borne viruses (BBV). The application of high efficiency leukocyte-removal filters to remove cell-associated BBV from blood has been somewhat successful in both laboratory and clinical trials (Rawal et al., Transfusion 29:460-62 (1989); Rawal et al., Blood 76:2159-61 (1990); Gilbert et al., Lancet 1:1228-31 (1989); de Graan-Hentzen et al., Transfusion 29:757-60 (1990)). However, these filters are unable to remove cell-free virions from blood or plasma. Thus, leukocyte-depleted blood from infected donors may retain the potential of transmitting hepatitis B (HBV), hepatitis C (HCV) and human immunodeficiency virus (HIV) to transfusion recipients.
Chemicals that are stable at room temperature, is compatible with blood samples and other biological fluids, and can kill microorganisms and viruses effectively in a relatively short period of time and methods of using same, can be of great importance and value in the prevention against various deadly diseases including AIDS, Hepatitis and several others that can be transmitted via blood and biological fluids.
Extensive studies have demonstrated the effectiveness of various chemical agents on the activity and growth of viral, bacterial and other organisms including human immunodeficiency virus, herpes virus, and gonorrhea. These agents include surfactants, purines or pyrimidines with ribose moiety, plant alkaloids, and antimutant agents.
In particular, Nonoxynol-9 and other nonionic surfactants have been employed as virucidal agents, but their use in blood samples and biological fluids is not acceptable due to their red cell lysing properties, or hemolytic effect, and their ability to alter proteins, enzymes and several other parameters that need to be tested in the blood samples. In particular, it is well known in the medical art that while chemical surfactants like Brij-35, Nonidet-P 40 and Nonoxynol-9 are capable of inactivating viruses by acting on the cell surface, proteins, and lipid layers, these chemicals can also damage the red cell surface if allowed to react for a prolonged period of time.
The applicant has considered the following patents and submits that the present invention is neither disclosed nor suggested therein: U.S. Pat. No. 4,012,494, U.S. Pat. No. 3,912,450, U.S. Pat. No. 3,867,517, U.S. Pat. No. 2,889,243, U.S. Pat. No. 2,380,166, U.S. Pat. No. 4,314,997, U.S. Pat. No. 4,164,565, U.S. Pat. No. 4,613,501, U.S. Pat. No. 4,806,463, U.S. Pat. No. 4,675,159, U.S. Pat. No. 4,978,688, U.S. Pat. No. 4,412,985, U.S. Pat. No. 4,924,624, U.S. Pat. No. 4,923,815, U.S. Pat. No. 4,833,165, U.S. Pat. No. 4,855,064, U.S. Pat. No. 4,471,054, U.S. Pat. No. 4,481,189, U.S. Pat. No. 4,841,023, and U.S. Pat. No. 4,764,369.
All U.S. patents and publications referred to herein are hereby incorporated by reference.